Human Research Compliance

For WMO-compliant research in which Radboudumc acts as sponsor or participating center, approval must be granted by the Radboudumc Executive Board prior to the start of the research. We coordinate the approval procedure and assess the content of the file as a means of quality assurance.

We handle the issuance of research monitor accounts for monitor visits by an external party. This allows external monitors, subject to permission, to view and verify data of Radboudumc research participants.

Researchers working on research subject to the WMO are required to follow the BROK. Research personnel working on research falling within the scope of the WMO, CTR, MDR or IVDR are required to take WMO GCP training (unless already in possession of a valid BROK certificate).

Our researchers can use our IQS (IKS, in Dutch) to obtain info on all phases of clinical research. We also offer a help desk, walk-in consultation and a bi-monthly newsletter.

This e-training has been developed to familiarize our employees involved in human-related research with the Radboudumc policy on human-related scientific research.

This training allows our employees to monitor research.

We offer training to improve patient information (PIF) writing skills of our researchers and research staff.

If you prefer to talk with us in person, we invite you to our walk-in consultation hours.